Open Heart Surgery PatientsNCT00248898
Quality of Life After Open Heart Surgery in Older Patients
An observational study of Open Heart Surgery Patients, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Long term follow-up of nonagenarians who have undergone open heart procedures. Read more about this study
- Who is it for?
- Ages 90 years and older
- Conditions the study is for
- Open Heart Surgery Patients
- What is being tested?
- Cardiac Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: A (consecutive) series of 49 patients age 90 years or older underwent cardiac operations between May 1995 and October 2004 at New York Presbyterian Hospital-Weill Medical College of Cornell University.
Who may be able to join
- Patients who underwent open heart procedures and who were 90 years or greater between 1995 and 2004 at The New York Presbyterian Hospital
Who cannot join
- Patients who refuse follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Presbyterian Hospital - Weill Medical Center
New York, New York, 10021
About this study
Long term follow-up of nonagenarians who have undergone open heart procedures.
Read the detailed description
Based on population studies, life expectancy at age 80 is 8.5 years, and at the age of 85 years, it is 6.3 years (US Bureau of Census 2000). There are currently 1.6 million nonagenarians and roughly 72,000 centenarians living in the United States. With this increasing elderly population, knowledge of the special management issues and long-term sequela are imperative. Bacchetta and coworkers from our institution presented a 10-year outcomes experience in nonagenarians undergoing cardiac surgery. In 42 consecutive patients, in-hospital mortality was 7%, and 30-day mortality 5%. Postoperative morbidity was documented in 67% with arrhythmias accounting for 31% of the cases, followed by respiratory complications, infections, and strokes. While this is mostly in-hospital data, long-term follow-ups have not been performed.
- Conditions
- Open Heart Surgery Patients
- Being tested
- Cardiac Surgery
- Keywords
- nonagenarians, quality of life, cardiothoracic surgery, long term survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
Coronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, aortic aneurysm repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Heart Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl H Krieger, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248898
- Sponsor's protocol ID
- 0501007700
- Status last verified
- Jan 2017
- First submitted
- 3 Nov 2005
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Investigators may contact the PI for access to the data, with their planned analyses
Publications
Ullery BW, Peterson JC, Milla F, Wells MT, Briggs W, Girardi LN, Ko W, Tortolani AJ, Isom OW, Krieger KH. Cardiac surgery in select nonagenarians: should we or shouldn't we? Ann Thorac Surg. 2008 Mar;85(3):854-60. doi: 10.1016/j.athoracsur.2007.10.074.
PubMed 18291156
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Open Heart Surgery in Older Patients
- ClinicalTrials.gov ID
- NCT00248898
- Acronym / sponsor ID
- 0501007700
- Conditions
- Open Heart Surgery Patients
- Keywords
- nonagenarians, quality of life, cardiothoracic surgery, long term survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term follow-up of nonagenarians who have undergone open heart procedures.
Detailed description
Based on population studies, life expectancy at age 80 is 8.5 years, and at the age of 85 years, it is 6.3 years (US Bureau of Census 2000). There are currently 1.6 million nonagenarians and roughly 72,000 centenarians living in the United States. With this increasing elderly population, knowledge of the special management issues and long-term sequela are imperative. Bacchetta and coworkers from our institution presented a 10-year outcomes experience in nonagenarians undergoing cardiac surgery. In 42 consecutive patients, in-hospital mortality was 7%, and 30-day mortality 5%. Postoperative morbidity was documented in 67% with arrhythmias accounting for 31% of the cases, followed by respiratory complications, infections, and strokes. While this is mostly in-hospital data, long-term follow-ups have not been performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A (consecutive) series of 49 patients age 90 years or older underwent cardiac operations between May 1995 and October 2004 at New York Presbyterian Hospital-Weill Medical College of Cornell University.
Key inclusion criteria (1 listed)
- Patients who underwent open heart procedures and who were 90 years or greater between 1995 and 2004 at The New York Presbyterian Hospital
Key exclusion criteria (1 listed)
- Patients who refuse follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac SurgeryCoronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, aortic aneurysm repair | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Background: PubMed 18291156Ullery BW, Peterson JC, Milla F, Wells MT, Briggs W, Girardi LN, Ko W, Tortolani AJ, Isom OW, Krieger KH. Cardiac surgery in select nonagenarians: should we or shouldn't we? Ann Thorac Surg. 2008 Mar;85(3):854-60. doi: 10.1016/j.athoracsur.2007.10.074.
- Individual participant dataSharing planned: Yes. Investigators may contact the PI for access to the data, with their planned analyses
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Graft Patency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl H Krieger, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Heart Surgery Patients, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00248898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.